MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, on (b)(6) 2024, a long-term palindrome chronic catheter was implanted in the patient's neck for ongoing dialysis.The patient has been undergoing thrice-weekly scheduled dialysis sessions since then.On the day of the event, at 12:11, the nurse prepared the catheter for use by disinfecting the venous end, aspirating heparin solution, and connecting a 10 ml syringe to test the catheter's functionality.During the process, a crack was observed at the threaded connection of the venous port (luer adapter).Blood was drawn, and no leakage was detected.The complication was immediately reported to the physician, head nurse, and director.A double-lumen catheter was subsequently connected, with low-flow dialysis initiated.Throughout the procedure, the patient and catheter were closely monitored, with no abnormalities observed.The patient was informed that the venous port interface would be scheduled for replacement.The catheter was not repaired.There was no leak.Tego was not utilized.The insertion site was not treated prior to product placement.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, on (b)(6) 2024, a long-term palindrome chronic catheter was implanted in the patient's neck for ongoing dialysis.The patient has been undergoing thrice-weekly scheduled dialysis sessions since then.On the day of the event, at 12:11, the nurse prepared the catheter for use by disinfecting the venous end, aspirating heparin solution, and connecting a 10 ml syringe to test the catheter's functionality.During the process, a crack was observed at the threaded connection of the venous port (luer adapter).The catheter was not repaired.Tego was not utilized.The insertion site was not treated prior to product placement.Blood was drawn, and no leakage was detected.The complication was immediately reported to the physician, head nurse, and director.As an intervention, a double-lumen catheter was subsequently connected, with low-flow dialysis initiated.Throughout the procedure, the patient and catheter were closely monitored, with no abnormalities observed.As a remedial action, the patient was informed that the venous port interface would be scheduled for replacement.The procedure was completed after the remedial action.The catheter was in place for 1 year.There was no blood loss, and blood transfusion was not required.There was no reported patient injury.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: jon cornell ; 15 hampshire street mansfield; mansfield, MA 02048 ; 8772111850
• MDR Report Key: 23512212
• Report Number: 1282497-2025-00632
• Device Sequence Number: 15856421
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: (01)10884521013148(17)280717(10)2318500147
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 2318500147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/11/2025
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown